BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN 4.0MM MOTIONLOC SCREW

    MDR report key: 23618088 · Received November 21, 2025

    Report

    Report Number
    0001822565-2025-04261
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    July 29, 2025
    Report Date
    November 20, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    PMA / PMN Number
    K123918
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). E1: FULL ESTABLISHMENT NAME - (B)(6). G2: FOREIGN - THE EVENT OCCURRED IN SHOUTH KOREA. G2: LITERATURE - KIM, J., OH, C., HAN, S., & KIM, H. (2025). MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR HUMERAL SHAFT FRACTURES WITH THE FAR CORTICAL LOCKING SYSTEM: A MATCHED COMPARISON WITH THE STANDARD LOCKED PLATING CONSTRUCT. INJURY, 56(10), 112635. HTTPS://DOI.ORG/10.1016/J.INJURY.2025.112635. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE REPORTED EVENT IS NOT CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE WAS OBTAINED THAT REPORTED A PROSPECTIVE STUDY. THE PURPOSE OF THE STUDY WAS TO ANALYZE AND COMPARE THE RADIOLOGICAL AND FUNCTIONAL OUTCOMES OF DIAPHYSEAL HUMERAL FRACTURES TREATED WITH THE MIPO TECHNIQUE (MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS) USING EITHER FCL (FAR CORTICAL LOCKING) OR LP (STANDARD LOCKING PLATE). PATIENTS WERE DIVIDED INTO 2 GROUPS. THE STUDY REPORTED 1 PATIENT EXPERIENCED SCREW BREAKAGE AT THE PROXIMAL SEGMENT OF THE FRACTURE, LEADING TO REDUCTION LOSS AFTER ONE MONTH. THIS WAS REVISED TO A STANDARD LOCKING PLATE WHICH EVENTUALLY HEALED. (PATIENT IMAGES IN FIGURES 5 AND 6). ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926780 UNKNOWN 4.0MM MOTIONLOC SCREW PLATE, FIXATION, BONE HRS ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H